rope01 rope02

Clinical Trials

Turning Point Therapeutics is a clinical-stage biopharmaceutical company currently enrolling eligible patients in TRIDENT-1, a study of repotrectinib in patients with certain solid tumor cancers.

TRIDENT-1

A Study of Repotrectinib (TPX-0005) in Patients with Advanced Solid Tumors Harboring ALK, ROS1 or NTRK1-3 Rearrangements

TRIDENT-1 is enrolling patients in a Phase 1/2 multi-center trial evaluating our lead drug candidate, repotrectinib, for the treatment of patients with ROS1+ advanced non-small cell lung cancer (NSCLC) as well as patients with ROS1+, NTRK+ or ALK+ advanced solid tumors. Repotrectinib is being assessed for safety, tolerability, pharmacokinetics and antitumor activity.

Tumors with ROS1, NTRK and ALK gene mutations or rearrangements have a higher likelihood of developing resistance to existing targeted therapies. In many cases, these mutations prevent existing treatments from targeting and treating the tumor as effectively. Repotrectinib is designed to be smaller and less bulky than existing targeted therapies, and may circumvent some the resistance mechanisms found in tumors with ROS1, NTRK and ALK mutations.

A Precision Oncology Approach

The TRIDENT-1 study will be using next-generation sequencing to determine whether tumor cells carry the genetic mutations of interest: ROS1, NTRK, ALK. These genetic tests help identify patients with tumors that are most likely to respond to treatment.

Where are the trials located?

TRIDENT-1 study locations are currently open. Visit the TRIDENT-1 page at www.ClinicalTrials.gov for a list of active sites.

How can I learn more?

Visit www.ClinicalTrials.gov.
Visit the TRIDENT-1 study website: https://trident1study.com.
If you have questions about our clinical trials, contact us via email at clinical@tptherapeutics.com or by phone at 858-276-0005.

Compassionate Use

Access to Investigational Medicines

Turning Point Therapeutics is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. You can learn more about our ongoing clinical trials on our website or on ClinicalTrials.gov.

In some cases, we may be able to provide patients access to our investigational drugs outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of investigational drugs outside of a clinical trial is known as “Expanded Access” but may go by other names.

Expanded Access, also known as Compassionate Use, is the use of an investigational medical product prior to FDA approval and outside of use in a clinical trial. Turning Point accepts Single Patient Expanded Access requests for pre‑approval access to investigational drugs from physicians only.

Eligibility Requirements

Single Patient Expanded Access may not always be available and requires the individual patient meet certain eligibility conditions. To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria:

  • Diagnosed with a serious, life-threatening or severely debilitating disease;
  • Unable to participate in Turning Point Therapeutics clinical trials; and
  • Have no comparable or satisfactory alternative treatment option available.

In addition, we will consider providing Expanded Access only if the risk/benefit profile of the investigational drug is favorable in light of the sufficient safety and efficacy information and the treating physician’s assessment of the patient’s medical condition.

Turning Point is committed to a fair and impartial evaluation of each request, however, meeting the above criteria does not guarantee access to an investigational drug.

How to Apply

Physician requests can be submitted through our Compassionate Use portal.

Patients interested in obtaining access to a Turning Point investigational medicine must do so via their physician.

Review Process

Medical professionals at Turning Point Therapeutics will individually review each request, consistent with our policy on pre-approval access and the program eligibility requirements. Turning Point is committed to a fair and impartial evaluation of each request, however, meeting the above criteria does not guarantee access to an investigational drug.

This policy is subject to change.